PMA P940010S014
- Device
- OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S014
- Product code
- MVG
- Decision date
- 2018-01-30
- Classification
- System, Laser, Fiber Optic, Photodynamic Therapy
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Approval order statement
- Replace the current final diffuser tip axial load test method with a test method that is currently performed as an in-process diffuser tip axial load test and to eliminate the requirement for an in-process diffuser tip axial load test.
Current openFDA PMA Record#
- Device
- OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S014
- Product code
- MVG
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Decision date
- 2018-01-30
- Decision code
- OK30
- Date received
- 2018-01-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replace the current final diffuser tip axial load test method with a test method that is currently performed as an in-process diffuser tip axial load test and to eliminate the requirement for an in-process diffuser tip axial load test.